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Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.

NCT ID: NCT00151359

Last Updated: 2005-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2002-02-28

Brief Summary

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Our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . As a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. However, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a U.S. patent for the design concept. However, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. Also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin.

Detailed Description

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Conditions

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Sensation Disorder

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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SoleSensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged 65 to 75 years

Exclusion Criteria

* Any neurological or musculoskeletal ailments that affect their balance
* Any drugs that affect balance
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Wilfrid Laurier University

OTHER

Sponsor Role lead

Principal Investigators

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Stephen D Perry, PhD

Role: PRINCIPAL_INVESTIGATOR

Wilfrid Laurier University

Brian E Maki, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Studies In Aging, Sunnybrook & Women's

Geoff R Fernie, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Studies In Aging, Sunnybrook & Women's

Locations

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WLU Biomechanics Laboratory

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

References

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Perry SD, Santos LC, Patla AE. Contribution of vision and cutaneous sensation to the control of centre of mass (COM) during gait termination. Brain Res. 2001 Sep 14;913(1):27-34. doi: 10.1016/s0006-8993(01)02748-2.

Reference Type BACKGROUND
PMID: 11532244 (View on PubMed)

Other Identifiers

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PPP-53686

Identifier Type: -

Identifier Source: org_study_id